Home NDC 0093-3196 Cefadroxil
Product NDC 0093-3196
11-digit product format 000933196
Labeler code 0093
Product ID 0093-3196_86b8951f-3699-4888-9eeb-7bbda995ec35
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cefadroxil
Dosage form CAPSULE
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
Application ANDA065282
Marketing category ANDA
Marketing start 2007-01-31
Substance CEFADROXIL
Active strength 500 mg/1
Pharmacologic classes Cephalosporin Antibacterial [EPC], Cephalosporins [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065282-001 CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065282-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065282-001 CEFADROXIL EQ 500MG BASE CAPSULE / ORAL AB RS 2006-01-20 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Cefadroxil
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CEFADROXIL 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 280111G160 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309049 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0093-3196-01 Cefadroxil 100 in 1 BOTTLE CAPSULE 100 15 0093-3196-53 Cefadroxil 50 in 1 BOTTLE CAPSULE 50 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded CEFADROXIL ACTIVE INGREDIENT 280111G160 CEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA INC] 8 CEFADROXIL ANHYDROUS ACTIVE MOIETY Q525PA8JJB CEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA INC] 8 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 CEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA INC] 8 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA INC] 8 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA INC] 8 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD CEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA INC] 8 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK CEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA INC] 8 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA INC] 8 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 CEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA INC] 8 GELATIN INACTIVE INGREDIENT 2G86QN327L CEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA INC] 8 INDIGOTINDISULFONATE SODIUM INACTIVE INGREDIENT D3741U8K7L CEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA INC] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA INC] 8 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA INC] 8 SHELLAC INACTIVE INGREDIENT 46N107B71O CEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA INC] 8 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA INC] 8 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA INC] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA INC] 8 CEFADROXIL ACTIVE INGREDIENT 280111G160 CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 CEFADROXIL ANHYDROUS ACTIVE MOIETY Q525PA8JJB CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 ALUMINUM OXIDE INACTIVE INGREDIENT LMI26O6933 CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 GELATIN INACTIVE INGREDIENT 2G86QN327L CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 SHELLAC INACTIVE INGREDIENT 46N107B71O CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP CEFADROXIL CAPSULE [PD-RX PHARMACEUTICALS, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-3196 CEFADROXIL CAPSULE [TEVA PHARMACEUTICALS USA, INC.] 15 Current NDC, Legacy NDC, 2 package rows 20250306_bda86975-8c2f-4c4e-9a4c-a1a959f9336a.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0093-3196-01 00093319601 100 CAPSULE in 1 BOTTLE (0093-3196-01) 100 capsule 2007-01-31 0000-00-00 No No Current 0093-3196-53 00093319653 50 CAPSULE in 1 BOTTLE (0093-3196-53) 50 capsule 2007-01-31 0000-00-00 No No Current